A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
Enrolling by invitation · Phase 1/Phase 2
Conditions studied: Cancer, Solid Tumor
In brief
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
Key facts
- Study ID
- NCT05741242
- Run by
- Jaime Leandro Foundation for Therapeutic Cancer Vaccines
- People needed
- 136
- Starts
- 2022-11-30
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
- Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
- Psychiatric illness or social situations that would limit compliance with study requirements.
- History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
- Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
- Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
- Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.
Where it is running
- Precision NextGen Oncology & Research Center — Beverly Hills, California, United States
- Quest Clinical Research — San Francisco, California, United States
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
- St. Louis Cancer Care — Bridgeton, Missouri, United States
- Anna Gattani MD PC — New York, New York, United States
Full record on ClinicalTrials.gov
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